- DecisionDx-Melanoma by Castle Biosciences (CSTL, Financial) shows a 2.8% sentinel lymph node positivity rate in low-risk melanoma patients.
- The test significantly outperforms current AJCC staging and CP-GEP, which showed a 6.2% positivity rate.
- Findings support using this test to avoid unnecessary sentinel lymph node biopsy (SLNB) surgeries and improve clinical decision-making.
Castle Biosciences, Inc. (CSTL) has unveiled a new study that highlights the efficacy of its DecisionDx®-Melanoma test. This examination indicates the test’s capacity to identify melanoma patients at low risk of sentinel lymph node (SLN) positivity, surpassing the performances of the American Joint Committee on Cancer (AJCC) staging and the CP-GEP test model. The DecisionDx-Melanoma test achieved a 2.8% SLN positivity rate, significantly under the National Comprehensive Cancer Network’s (NCCN) 5% threshold, allowing patients to potentially forgo the sentinel lymph node biopsy (SLNB) surgery.
Published in Cancer Diagnosis & Prognosis, the study analyzed T1-T2 melanoma tumors across various validation studies. While the CP-GEP model classified low-risk patients at a 6.2% positivity rate, DecisionDx-Melanoma delivered a markedly better performance, showcasing its potential to improve clinical management of melanoma significantly. This advancement is particularly crucial as over 90% of patients with T1-T2 tumors undergoing SLNB receive negative results, emphasizing the importance of accurate risk assessment tools to avoid unnecessary procedures.
The study underscores the DecisionDx-Melanoma's ability to guide SLNB decisions, especially in patients with thin tumors where the risk of surgical complications may exceed the benefits. By offering personalized risk assessments, it aids in more informed decision-making regarding SLN positivity and melanoma recurrence, reinforcing the test's clinical value and potential market impact.
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